Orgaran 750 anti-Xa units/0.6ml Solution for injection

Read all of this leaflet carefully before you are given this medicine.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or your pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1. What Orgaran is and what it is used for
2. Before you use Orgaran
3. How to use Orgaran
4. Possible side effects
5. How to store Orgaran
6. Further information

Do not use Orgaran

• if you are allergic (hypersensitive) to danaparoid sodium or any of the other ingredients of Orgaran
• if you had a hemorrhagic stroke (due to a bleed in the brain) in the last three months
• if you have a bleed and it cannot be stopped
• if you have severely high blood pressure that can’t be helped
• if you have damage to the eye caused by diabetes
• if you have an infection of the heart valves (acute bacterial endocarditis)

if you are being given heparin (a frequently used antithrombotic) to treat blood clots you should not have a spinal or epidural anesthetic for surgery.

• tell your doctor if any of these applies to you

Take special care with Orgaran

• if you have or ever have had any of the following conditions:
  • former treatment with heparins (a group of frequently used antithrombotics) resulting in a large drop in the number of blood platelets (thrombocytopenia) and a blood test showing that Orgaran may cause a similar effect
  • tendency to bleed severely, for example haemophilia, or an increased bleeding risk
  • hepatic or renal disorders
  • ulcer(s) in the stomach or small intestine
  • hypersensitivity to sulphite, as this can cause severe allergic
  • reactions in asthma patients
• if Orgaran is used during heart bypass operation.
• in the case of medical examination or surgery for which a spinal/epidural injection is necessary. Extra supervision may be needed.

• tell your doctor if any of these applies to you

Using other medicines

• tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Orgaran may affect other medicines or be affected by them.

Medicines which may increase the risk of bleedings when taken at the same time as Orgaran:

• medicines used to dissolve blood clots
• aspirin and other anti-inflammatory drugs (like NSAIDs), for example for treatment of rheuma
• medicines that may cause ulcers (such as corticosteroids).

Using Orgaran with food and drinks

Food and drinks are not known to have effects on the effectiveness of Orgaran.

Pregnancy and breast-feeding

• tell your doctor if you are pregnant or might be pregnant, or if you are breast-feeding. Your doctor may still give you Orgaran if alternative medication is not available for you.

Driving and using machines

Orgaran is not known to have any effect on the ability to drive and use machines.

Important information about some of the ingredients of Orgaran

Orgaran contains sodium sulfite E221. Tell your doctor if you have ever had hypersensitivity to sulfite, as this can cause severe allergic reactions in asthma patients.

The dose

The dose for the prevention of blot clots is 1 ampoule (750 units), twice-a-day, for up to 14 days. Sometimes you may be given Orgaran for longer than this. Patients with a large drop in the number of blood platelets during heparin administration (thrombocytopenia, see Section 1) usually need higher doses.

Your doctor will work out the dose of Orgaran you need based on:

• the underlying disease you are suffering from
• the risk of blood clots
• the risk of bleeding
• your state of health and your physical characteristics (such as weight)
• whether or not you are hypersensitive to heparins

Orgaran may be given to children. Your doctor will take into account age and weight to determine to dose.

How Orgaran is given

Orgaran will be given to you by a doctor or nurse. Orgaran is given either as an injection under the skin or as an injection into a vein.

If you use more Orgaran than you should

As your doctor or nurse will be monitoring your condition carefully it is unlikely that you will be given too much Orgaran and, when needed, they will adjust doses.

If too high a dose is given you may notice unusual bleeding. This may show by:

• nosebleeds, bleeding gums
• blackened stools (may indicate blood loss from stomach or intestines)
• blood in the urine
• unusually heavy periods

• Tell your doctor or nurse if you notice any of these or other symptoms of unusual blood loss

If you forget to use Orgaran

As your doctor and nurse carefully check your medical condition, it is unlikely that you will receive too low a dose Orgaran. If needed, they will adjust the dose.

If you stop using Orgaran

Your doctor will decide when to stop Orgaran use.

What Orgaran contains

• The active substance is danaparoid sodium (750 anti-factor Xa units in 0.6 mL solution).
• The other ingredients are sodium sulphite E221, sodium chloride, water for injection, and hydrochloric acid (to adjust pH).

What Orgaran looks like and contents of the pack

Orgaran is a clear, colourless to pale yellow solution for injection.

It is available in glass ampoules (either 10 or 20 per box). Each ampoule contains 0.6 mL solution with 750 anti-factor Xa units danaparoid sodium.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

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Manufacturer: